Unparalleled Service

FDA Remediation – 483, Warning Letter, Consent Decree

We understand that the success or failure of your FDA remediation effort directly impacts your business and your financial future. We equip you with former FDA and Industry Experts who provide insight and hands-on experience. We work with your management team to evaluate current quality and compliance risks and implement effective solutions that make sense for your business. We assist with the preparation of FDA responses that implement corrective actions based on science and data; not emotion. Our team has a broad understand of regulatory expectations and an extensive background in FDA remediation.

Exemplar Compliance works with your organization to provide:

  • A Cooperative Working Environment
  • Scientifically Based Decisions
  • Solutions Focused on FDA Regulations and Guidance
  • CAPA Based Investigations and Corrective and/or Preventive Actions
  • Quality Deliverables That Meet Project Timelines & Regulatory Commitments
  • Remediation of Supporting Procedures, Work Instructions and Training (As Required)

Remediation Outside of the US

We perform gap assessment and remediation activities outside of the US:

  • Japan – MHLW
  • China – SFDA
  • Brazil – ANVISA
  • Canada – Health Canada
  • Europe – EMEA
  • UK – MHRA
  • Australia – TGA
  • and Others

Our former FDA and industry experts have an average of 25 years of experience.

Some of Our Work

FDA 483 Remediation for a Biologic Product

Our Client 1

We worked closely with our client to efficiently address 483 observations as part of a PreApproval Inspection. We able to used a CAPA format to thoroughly investigate each issue and provide a quick resolution.

FDA Warning Letter Response for a Drug Manufacturer

Our Client 2

We worked closely with our client to develop a comprehensive FDA Warning Letter Response package comprising of individual responses to each observation, objective evidence for all corrections made and, a detailed project plans to share with the US FDA.

FDA Class 1 Recall Response

Our Client 3

We assisted a foreign manufacturer with a class 1 recall and subsequent re-inspection of their facility by US FDA. The result was a “closed” recall and a successful inspection by FDA, enabeling them to keep their products on the market.

Contact us today for a free initial consultation.

We would love to hear about your project.

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